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Checkpoint Inhibitor

Nivolumab + Trametinib (+/- Ipilimumab) for Colorectal Cancer (CheckMate 9N9 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 months
Awards & highlights

CheckMate 9N9 Trial Summary

This trial is looking at a new combination treatment for people with colon or rectal cancer that has spread and who have already been treated.

Who is the study for?
This trial is for individuals with Stage IV colorectal cancer that has spread and was previously treated. They must have measurable disease, be in good physical condition (ECOG 0-1), and not have certain genetic mutations (BRAF V600). People can't join if they've had brain metastases, need systemic steroids or immunosuppressants, are allergic to the drugs being tested, or have used checkpoint inhibitors/MEK inhibitors before.Check my eligibility
What is being tested?
The study tests nivolumab combined with trametinib, with some participants also receiving ipilimumab. It aims to see how well these drugs work together in treating colorectal cancer that's spread after previous treatment. Participants will be randomly assigned to different drug combinations.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs (pneumonitis), skin issues, fatigue, digestive problems such as diarrhea or colitis, liver inflammation (hepatitis), hormonal gland issues like thyroid disorders and adrenal insufficiency.

CheckMate 9N9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My colorectal cancer is confirmed to be in stage IV and has been previously treated.

CheckMate 9N9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicity (DLTs)
Objective response rate (ORR) by investigator (Part 1B and Part 2)
Secondary outcome measures
Best overall response (BOR)
Disease control rate (DCR)
Duration of response (DOR)
+10 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Cardiac failure
2%
Sepsis
2%
Atrial fibrillation
2%
Embolism
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Pneumothorax
1%
Ileus
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Syncope
1%
Gastrointestinal haemorrhage
1%
Colitis
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Hypercalcaemia
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Bronchial obstruction
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

CheckMate 9N9 Trial Design

6Treatment groups
Experimental Treatment
Group I: Part 2 Cohort 5 (3L): RegorafenibExperimental Treatment1 Intervention
Group II: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinibExperimental Treatment3 Interventions
Group III: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinibExperimental Treatment3 Interventions
Group IV: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinibExperimental Treatment3 Interventions
Group V: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinibExperimental Treatment3 Interventions
Group VI: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Regorafenib
2014
Completed Phase 2
~1580
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include immune checkpoint inhibitors and targeted therapies. Nivolumab, a PD-1 inhibitor, works by blocking the programmed cell death protein 1 (PD-1) pathway, thereby enhancing the immune system's ability to attack cancer cells. Trametinib, a MEK inhibitor, targets the MEK enzyme in the MAPK/ERK pathway, which is often overactive in cancer cells, leading to reduced tumor growth. Ipilimumab, a CTLA-4 inhibitor, blocks the CTLA-4 protein on T cells, boosting the immune response against cancer cells. These mechanisms are crucial for colorectal cancer patients as they offer a way to target cancer cells more precisely and enhance the body's immune response, potentially leading to better outcomes.
Targeted Therapy and Checkpoint Immunotherapy Combinations for the Treatment of Cancer.

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Who is running the clinical trial?

NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,721,126 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,651 Previous Clinical Trials
4,130,339 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03377361 — Phase 1 & 2
~32 spots leftby Jun 2025